US8795339B2 - Adjustable-angle spinal fixation element - Google Patents

Abstract

A spinal fixation device is provided having first and second elongate members that are angularly adjustable relative to one another. Each elongate member can include a connecting feature formed on a terminal end thereof, and each connecting feature can be coupled to one another to allow angular movement of the first and second elongate members. The device can also include a locking mechanism that is adapted to couple to the connecting feature on each of the first and second elongate members to lock the elongate members in a fixed position relative to one another.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No. 10/708,919, filed on Mar. 31, 2004, entitled “Adjustable-Angle Spinal Fixation Element,” which is expressly incorporated herein by reference.

FIELD OF THE INVENTION

The present application relates to devices for use in spinal surgery, and in particular to spinal fixation devices having an adjustable angle.

BACKGROUND OF THE INVENTION

Stabilization of the spine is often required following trauma, tumor, or degenerative pathologies. Although each region of the spine presents unique clinical challenges, posterior fixation of the cervical spine is particularly challenging. The anatomy of the cervical spine makes it a technically challenging area to instrument. Specifically, several vital neural and vascular structures, including the vertebral arteries, nerve roots, and spinal cord, must be avoided during surgery.

Current methods of posterior cervical stabilization include the use of an occipital spinal plate and a transition rod for fixation of the cervico-thoracic junction. Such devices typically include a spinal fixation element, such as a relatively rigid fixation rod, that is coupled to adjacent vertebrae by attaching the element to various anchoring devices, such as hooks, bolts, wires, or screws. Often two rods are disposed on opposite sides of the spinous process in a substantially parallel relationship. The fixation rods can have a predetermined contour that has been designed according to the properties of the target implantation site, and once installed, the rods hold the vertebrae in a desired spatial relationship, either until healing or spinal fusion has taken place, or for some longer period of time.

It is often the case that the predetermined contour of a fixation rod does not exactly fit the contour of the implantation site. This may be attributed to various factors including a patients age, which directly relates to the size of their spinous process, irregular contouring due to disease or injury, or malformation due to a birth defect. These conditions often make it impossible to use a pre-contoured fixation rod. In these cases, multiple rods projecting at multiple angles are used, however such devices can complicate the surgery, as well as the recovery, and they can add undue strain on the spinous process, possibly resulting in an unsuccessful repair of the spine.

Accordingly, there presently exists a need for improved spinal fixation devices that can be easily installed and that allow for angular adjustment and subsequent locking. There is also a need for spinal fixation devices that have a low-profile to avoid potential irritation and injury to the patient.

SUMMARY OF THE INVENTION

The present invention generally provides a spinal fixation device having first and second elongate members that are angularly adjustable relative to one another. Each elongate member can include a connecting feature formed on a terminal end thereof, and each connecting feature can be coupled to one another to allow angular movement of the first and second elongate members. The device can also include a locking mechanism that is adapted to couple to the connecting feature on each of the first and second elongate members to lock the elongate members in a fixed position relative to one another.

In one embodiment, the connecting feature on the first elongate member is a female connector, and the connecting feature on the second elongate member is a male connector that is adapted to receive the female connector. The female connector preferably includes opposed arms defining a recess therebetween for receiving the male connector. A bore can extend through the opposed arms on the female connector and through the male connector for receiving a central mating element that is adapted to mate the male and female connectors to one another. In an exemplary embodiment, the central mating element is a cylindrical member that is adapted to allow at least one of the first and second elongate members to rotate thereabout. More preferably, however, the cylindrical member is fixedly coupled to a portion of the female connector, and the male connector is free to rotate about the cylindrical member.

In use, the locking mechanism can engage the cylindrical member to prevent movement of the male connector relative to the female connector. While a variety of locking mechanisms can be used, in one embodiment the locking mechanism can be in the form of a slot extending through the male connector such that the male connector is in the form of a clamp, and the locking mechanism can also include a fastening element that is adapted to engage the male connector to clamp the cylindrical member within the bore. The fastening element is preferably a threaded member.

In other aspects of the present invention, the connecting feature on each of the first and second elongate members can rotate about a central axis extending substantially perpendicular to an axis of each first and second elongate members. More preferably, each connecting feature can include opposed inner and outer surfaces, and the inner surface on each connecting feature can be in contact one another. In an exemplary embodiment, the inner surface on each connecting feature is adapted to prevent rotation of the first and second elongate members relative to one another when the locking mechanism is in a locked configuration. The connecting features can also optionally include anti-rotation features, such as gear teeth, formed on the inner surface of each connecting feature.

In further aspects, a first bore can extend through the inner and outer surface of the connecting feature on the first elongate member and a second bore extending through the inner and outer surface of the connecting feature on the second elongate member. In one embodiment, the bores can be adapted to receiving the locking mechanism, which can be, for example, a fastening element having a head and a shaft with threads formed thereon. The first bore is preferably non-threaded for freely rotatably receiving a portion of the shaft of the fastening element, and the second bore is preferably threaded for mating with the threads formed on the shaft of the locking mechanism.

In an alternative embodiment, a pin member can be disposed through the first and second bores extending through the inner and outer surfaces of the connecting feature, and the pin member can include a transverse bore extending therethrough for receiving at least a portion of the locking mechanism. A receiving bore can be formed in at least one connecting feature, and the receiving bore can be in communication with the central bore to allow the locking mechanism to extend therethrough and into the transverse bore in the pin member. In a further embodiment, the locking mechanism can be adapted to engage the pin member to translate the first and second connecting features toward one another to lock the first and second elongate members in a fixed position relative to one another.

In yet another embodiment of the present invention, the connecting feature on each of the first and second elongate members can be slidably coupled to one another. More preferably, the connecting feature on each of the first and second elongate members is a substantially curved terminal portion, and the terminal portion are complementary for slidably mating to one another. Each terminal portion can include a slot formed therein for receiving the locking mechanism. Each terminal portion can also include one or more anti-sliding surface features formed on a portion thereof to prevent movement of the first and second elongate members relative to one another when the locking mechanism is in a locked configuration.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which:

FIG. 1A is an exploded view of one embodiment of an adjustable-angle spinal fixation device having male and female connecting features according to the present invention;

FIG. 1B is a side, assembled view of the adjustable-angle spinal fixation device shown inFIG. 1A in a locked position;

FIG. 1C is a perspective view of a central mating element of the adjustable-angle spinal fixation device shown inFIG. 1A;

FIG. 1D is an enlarged perspective view of a male connector of the adjustable-angle spinal fixation device shown inFIG. 1A;

FIG. 1E is an exploded view of another embodiment of an adjustable-angle spinal fixation device having a spinal fixation plate with a male connecting feature and a spinal rod with a female connecting feature for mating to the male connecting feature;

FIG. 2A is an exploded view of another embodiment of an adjustable-angle spinal fixation device according to the present invention having anti-rotation features formed thereon;

FIG. 2B is an enlarged side view of the adjustable-angle spinal fixation device shown inFIG. 2A in a locked position;

FIG. 3A is an exploded view of an adjustable-angle spinal fixation device having a pin member for receiving a fastening element according to yet another embodiment the present invention;

FIG. 3B is a perspective view of the adjustable-angle spinal fixation device shown inFIG. 3A in a locked position;

FIG. 4A is a perspective view of yet another embodiment of an adjustable-angle spinal fixation device according to the present invention having substantially curved complimentary matable connecting features;

FIG. 4B is a side view of the adjustable-angle spinal fixation device shown inFIG. 4A in a locked position;

FIG. 5A is a side view of another embodiment of an adjustable-angle spinal fixation device according to the present invention having a locking mechanism that provides a polyaxial connection with first and second spinal fixation elements coupled thereto;

FIG. 5B is a top perspective view of the adjustable-angle spinal fixation device shown inFIG. 5B in a locked position; and

FIG. 5C is a bottom perspective view of the adjustable-angle spinal fixation element shown inFIG. 5A in a locked position.

DETAILED DESCRIPTION OF THE INVENTION

The present invention provides various angularly-adjustable spinal fixation devices, each of which generally includes first and secondelongate members12a,12b, a connecting feature20 formed on a terminal end of each of the first and secondelongate members12a,12b, and alocking mechanism30 that is adapted to lock the first and secondelongate members12a,12bin a fixed position relative to one another. Theelongate members12a,12bare preferably spinal rods and/or plates that are used, for example, in the stabilization of the spine following trauma, tumor, or degenerative pathologies. Among many other advantages, the devices are particularly useful to allow a spinal rod to be positioned and locked in a desired angular orientation without the need to reshape the rod, and without requiring the point of adjustment to be attached to the spine of a patient.

FIGS. 1A-1B illustrate one exemplary embodiment of aspinal fixation device10 having first and secondelongate members12a,12b, a connectingfeature20a,20bformed on aterminal end14,16 of each of the first and secondelongate members12a,12b, and alocking mechanism30 that is adapted to lock the first and secondelongate members12a,12bin a fixed position relative to one another. In use, the first and secondelongate members12a,12bcan be angularly adjusted relative to one another and, once properly positioned, they can be locked in a fixed position relative to one another using thelocking mechanism30.

The first and secondelongate members12a,12bcan each have any shape or size, and eachelongate member12a,12bcan vary in diameter relative to one another. Theelongate members12a,12bcan also vary in length depending on the intended use. In the illustrated embodiment, the first and secondelongate members12a,12bare substantially cylindrical spinal rods, each having aterminal end13,15 that is adapted to mate to a spinal anchor, such as a hook, screw, bolt, plate, etc. The opposedterminal end14,16 of eachelongate member12a,12bincludes the connectingfeature20a,20bformed thereon and mated to one another.

While the terminal ends13,15 of theelongate members12a,12bshown inFIGS. 1A-1B extend along the axis of theelongate members12a,12b, the terminal ends13,15 can extend at an angle relative to theelongate members12,12b. For example, as shown inFIG. 1E, theterminal end13′ of one of the elongate members, e.g., the firstelongate member12a′, can extend at a 90° angle relative to the longitudinal axis of the secondelongate member12b, as shown inFIG. 1E. In other embodiments, one or both of the elongate members can be in the form of a spinal fixation plate. For example, as shown inFIG. 1E, the secondelongate member12bis in the form of aspinal fixation plate12b′, rather than a spinal rod.

Continuing to refer toFIGS. 1A-1B, each connectingfeature20a,20bcan have a variety of configurations, but they should be adapted to allow for angular adjustability of the first and secondelongate members12a,12brelative to one another. In the embodiment shown inFIGS. 1A-1B, the connectingfeature20aon the firstelongate member12ais in the form of a female connector, and the connectingfeature20bon the second elongate member12 is in the form of a male connector. The terminal ends14,16 of theelongate members12a,12bcan mate to theconnectors20a,20bat any location, but in an exemplary embodiment theelongate members12a,12bare positioned such that theconnectors20a,20bdo not interfere with the patient's spinal anatomy.

While the male andfemale connectors20a,20bcan have a variety of configurations, in an exemplary embodiment thefemale connector20ahas opposedarms23a,23bthat are spaced a distance apart from one another to form anopen recess26 therebetween for seating themale connector20b. Eacharm23a,23bcan vary in shape and size, but in an exemplary embodiment, as shown, thearms23a,23beach have a substantially circular shape. Themale connector20bcan also vary in shape and size, but it preferably has a shape that corresponds to the female connector22, and more preferably themale connector20bis substantially circular.

Eachconnector member20a,20balso preferably includes acentral bore28a,28bthat extends therethrough in a direction that is substantially perpendicular to a longitudinal axis L₁, L₂each of the first and secondelongate members12a,12b. The central bore28a,28bis adapted to receive acentral mating element29 therethrough for mating theconnectors20a,20b, and for allowing one or bothconnectors20a,20bto rotate thereabout. Thecentral mating element29 can have a variety of configurations, howeverFIG. 1C illustrates acentral mating element29 having a substantially cylindrical shape and including proximal anddistal ends29c,29d. In a preferred embodiment, one of the connectors, e.g., thefemale connector20a, is configured to receive themating element29 such that thefemale connector20aand themating element29 are in a fixed position relative to one another, and themale connector20bis free to rotate about themating element29 and relative to thefemale connector20a. This can be achieved, for example, by providing complementary features on themating element29 and thefemale connector20ato prevent rotation relative to one another. As shown inFIGS. 1A-1C, the portion of thebore28athat extends through thefirst arm23ahas a substantially square shape, and thedistal end29dof thecentral mating element29 includes a substantially square-shapedprotrusion29aformed thereon and adapted to be disposed within the corresponding bore28aformed in thefemale connector20a. As a result, when thedevice10 is in use, thefemale connector20ais locked in a fixed position relative to themating element29, but themale connector20bis free to rotate thereabout. A person skilled in the art will appreciate that the complementary features on themating element29 and thefemale connector20acan have a variety of other configurations and by way of non-limiting example, the complementary mating features can have a hexagonal shape, an octagonal shape, a D-shape, or any other shape that prevents rotation of thefemale connector20arelative to themating element29. In other embodiments, themating element29 and thefemale connector20acan be fixedly mated to one another, for example, by welding the components together, to prevent rotation of thefemale connector20arelative to themating element29.

As previously stated, thedevice10 also includes alocking mechanism30 that is adapted to lock the first and secondelongate members12a,12bin a fixed position relative to one another. While virtually any technique can be used to lock theelongate members12a,12bin a fixed position,FIGS. 1A,1B, and1D illustrate an exemplary embodiment of alocking mechanism30. In this embodiment, themale connector20bis in the form of a clamp mechanism and more particularly it includes aslot25 extending therethrough and in communication with the central bore28 formed therein, as shown in more detail inFIG. 1D. Theslot25 separates themale connector20binto upper andlower portions24a,24bthat are movable between an open position and a closed position in which themale connector20bis adapted to engage themating element29 extending through thecentral bore28b.

In order to move the upper andlower portions24a,24bto the closed position, the male connector24 can include a receivingbore28cformed therein and extending through the upper andlower portions24a,24b. The receiving bore28cis adapted to receive afastening element27 that is effective to pull one or both of the upper andlower portions24a,24btoward one another to close theslot25. As a result, thecentral bore28bextending through themale connector20bis decreased in size, thereby allowing themale connector20bto engage themating element29 and preventing rotation of the secondelongate member12brelative to the firstelongate member12a.

Thefastening element27 that is disposed through the receiving bore28ccan have a variety of configurations, and it can be, for example, a screw, anchor, or bolt. In the illustrated embodiment, as shown inFIG. 1A, thefastening element27 is a threaded member, e.g., a screw, having ahead27aand athread shank27b. The receiving bore28cformed in themale connector20bcan thus includes threads formed therein for mating with the threadedshank27bon thefastening element27. More preferably, however, the portion of the receiving bore28cformed in theupper portion24aof themale connector20bis non-threaded to allow free rotation of the threadedmember27 with respect thereto, and the portion of the receiving bore28cformed in thelower portion24bof themale connector20bis threaded to mate with the threadedshank27b. This allows thefastening element27 to pull theupper portion24atoward thelower portion24b, thereby locking theportions24a,24brelative to one another and locking themale connector20brelative to themating element29.

Those skilled in the art will appreciate that the receiving bore28bandmale connector20bcan be a variety of other configurations to facilitate locking of themale connector20b. By way of non-limiting example, thecentral mating element29 and/or an inner surface of thebore28bon themale connector20bcan have anti-rotation features formed thereon, such that when themale connector20bis closed the anti-rotation features can assist in securing themale connector20baround thecentral mating element29. The anti-rotation features can be, for example, a non-slip coating applied to the surface of themating element29 and/or thebore28b, teeth or knurling formed on the surface of themating element29 and/or thebore28b, or other gripping features known to one skilled in the art.

In use, thefastening element27 can be partially threaded into thebore28cformed in themale connector20bto allow the first and secondelongate members12a,12bto rotate relative to one another. Although theelongate members12a,12bcan be adapted for multi-axial rotation, in the illustrated embodiment theelongate members12a,12brotate along a single plane. Eachelongate member12a,12bmay be configured to rotate such that a complementary angle α_cbetween theelongate members12a,12b, as shown inFIG. 1B, can range from about 0° to 135° in each direction from a coaxial position, and more preferably from about 60° to 135° in each direction from a coaxial position. Once theelongate members12a,12bare in a desired position relative to one another, which is typically as a result of attaching the terminals ends13,15 of theelongate members12a,12bto an anchoring device, thefastening element27 can be fully threaded into thebore28cin themale connector20bto cause themale connector20bto engage themating element29, thereby preventing rotation of the secondelongate member12brelative to the firstelongate member12a.

FIGS. 2A-2B illustrate another embodiment of aspinal fixation device100 according to the present invention. In this embodiment, thespinal fixation device100 includes a first elongate member112ahaving a first connectingfeature120aformed thereon that is matable to a second connectingfeature120bformed on a secondelongate member112b. Each connecting feature120a,120bcan have any shape and size, but in the illustrated embodiment the connectingfeatures120a,120bhave a substantially circular shape. Each connecting feature120a,120balso includes opposed inner andouter surfaces114a,114b,116a,116b, and theinner surface114a,116aof each connecting feature120a,120bis adapted to be positioned adjacent to one another. As a result, theelongate members112a,112bare offset from each other such that they are parallel to a plane of rotation. While not shown, one or bothelongate members112a,112bcan optionally be angled at any orientation relative to the plane of rotation, such that the elongate member(s)112a,112bintersects the plane of rotation.

Continuing to refer toFIGS. 2A-2B, the connectingfeatures120a,120balso each include acentral bore122a,122bextending through the inner andouter surfaces114a,114b,116a,116bthereof and adapted to receiving alocking mechanism127. Thelocking mechanism127, when disposed through thecentral bores112a,112b, allows theconnectors120a,120b, and consequently the first and secondelongate members112a,112b, to rotate there around. In an exemplary embodiment, eachelongate member112a,112bcan rotate 360° relative to one another. One skilled in the art will appreciate that certain applications may require a range of rotation of less than 360°, in which case a restriction, such as a mechanical stop, may be introduced to limit the range of rotation.

Thelocking mechanism127 can have a variety of configurations, but in an exemplary embodiment, as shown, thelocking mechanism127 is a threaded member, e.g., a screw, that is similar to threadedmember27 shown inFIGS. 1A-1D. Thecentral bore122bin the firstelongate member120acan be configured to freely, rotatably receive thefastening element127, and thecentral bore122ain the secondelongate member120bcan be threaded to mate with the threadedshank127bof thefastening element127. In use, when thefastening element127 is in an unlocked position, it allows the first and secondelongate members112a,112bto freely rotate relative to one another. Once properly positioned, thefastening element127 can be fully threaded into thecentral bore122bin the secondelongate member120b, as shown inFIG. 2B, to lock theconnectors120a,120bin a fixed position relative to one another, thereby preventing rotation of the first and secondelongate members112a,112b.

The configuration of thelocking mechanism127 onspinal fixation device100 is particularly advantageous for use in lumbar or sacral-pelvic fixation. In particular, thefastening element127 extends through the connectingfeatures120a,120bin a direction that is substantially perpendicular to the plane of rotation of theelongate members112a,112b, thus allowing an insertion tool, such as a driver tool, to be used to thread thefastening element127 into the connectingfeatures120a,120bwhen thedevice100 is implanted.

In a further embodiment, theinner surface114a,116aof eachconnector120a,120bcan optionally include one or more anti-rotation features formed thereon. The anti-rotation features are effective to facilitate locking of the first and secondelongate members112a,112bin a fixed position relative to one another. While various anti-rotation features can be used, eachconnector120a,120bcan includegear teeth118a,118bformed thereon for engaging one another when thelocking mechanism127 is fully locked relative to theconnectors120a,120b. In an exemplary embodiment, thegear teeth118a,118bhave a size that allows angular positioning of the first and secondelongate members112a,112bin 4° increments relative to one another, however any increment can be used.

FIGS. 3A-3B illustrate yet another embodiment of aspinal fixation device100′ in accordance with the present invention. Thedevice100′ is similar to thedevice100 shown inFIGS. 2A-2B, and thus like reference numbers are used to refer to like parts. In this embodiment, the locking mechanism differs in that it includes apin member127′, rather than a threadedmember127, that extends through thecentral bore122a,122bin eachconnector120a,120b. The locking mechanism also includes afastening element130′ that is adapted to at least partially extend into thepin member127′ to lock theconnectors120a,120bin a fixed position. The orientation of thefastening element130′ is particularly advantageous for use in occipital-cervical fixation since thefastening element130 ′ extends through the connectingfeature120bin a direction that is substantially parallel to the plane of rotation of theelongate members112a,112b.

Thepin member127′ can have a variety of shapes and sizes, but in an exemplary embodiment it hashead127a′ and ashank127b′ having a substantially cylindrical shape to allow theconnector members120a′,120b′ to rotate there around. Thehead127a′ of thepin member127′ is configured to sit within arecess132′ formed within an opening of thecentral bore122a′ extending through thefirst connector120a′. Theshank127b′ of thepin member127′ is configured to extend through and sit within thebore122a′,122b′ in eachconnector120a′,120b′, and it includes atransverse bore128′ formed therein for receiving a portion of afastening element130′.

Thefastening element130′ preferably includes a proximal threadedshank131a′ that is adapted to mate with a threaded receiving bore132′ formed in thesecond connector120b′, and a distalnon-threaded shank131b′ that is adapted to extend into thetransverse bore128′ formed in thepin member127′. In use, thefastening element130′ can be partially threaded into the threaded bore132′ formed in thesecond connector120b′ to allow rotation of the first and secondelongate members112a′,112b′ relative to one another. In this position, thenon-threaded shank131b′ on thefastening element130′ extends into thetransverse bore128′ in thepin member127′, and it preferably loosely engages thebore128′ to allow rotation between thefirst connector120a′ and thesecond connector120b′. Further threading of thefastening element130′ into the threaded bore132′ will lock the angular position of the first and secondelongate members112a′,112b′ relative to one another, as shown inFIG. 3B. While various techniques can be used to lock the first and secondelongate members112a′,112b′ relative to one another, in one embodiment the this can be achieved by forming thetransverse bore128′ in thepin member127′ at a location that is axially offset from the receiving bore132′ in thesecond connector120b′ when thepin member127′ is fully disposed therein. Thus, upon further rotation of thefastening element130′ into the receiving bore132′, thenon-threaded shank131b′ causes thefirst connector120a′ to translate further toward thesecond connector120b′, thereby locking theconnectors120a′,120b′ in a fixed position relative to one another. In this fixed position, the head of127a′ of thepin member127′ is preferably fully seated within therecess132′ formed in thebore122a′ of thefirst connector120a′. In other embodiments, thetransverse bore128′ and thenon-threaded shank131b′ can contain features to translation and/or locking of theconnectors120a′,120b′. For example, a portion of theshank131b′, e.g., a distal end, and a portion of thetransverse bore128′, e.g., an opening, can include conforming chamfers formed thereon.

As previously described with respect toconnector100 shown inFIGS. 2A-2B, an inner surface of eachconnector120a′,120b′ can include anti-rotation features formed therein, such as gear teeth or knurling to prevent rotation of the first and secondelongate members112a′,112b′ relative to one another when thedevice100′ is in the locked configuration.

FIGS. 4A-4B illustrate yet another embodiment of aspinal fixation device400 in accordance with the present invention. In this embodiment, the connectingfeatures420a,420bon the first and secondelongate members412a,412beach have a substantially elongate, curved configuration such that they include complimentarymatable surfaces470,472. One of the connecting features, e.g., the first connectingfeature420a, can include an elongate slot or opening422aformed therein, and the other connecting feature, e.g., the second connectingfeature420b, can include a threadedbore422bformed therein. Theslot422aand bore422bare configured to receive alocking mechanism430 that is effective to lock the firstelongate member420ain a fixed position relative to the secondelongate member420b. In an exemplary embodiment, thelocking mechanism430 includes threadedmember432 that can be disposed through theslot422ain the firstelongate member420a, and that is matable with the threaded bore422bin the secondelongate member420b.

In use, when thefastening element432 is partially threaded into the threaded bore422b, the first andsecond connectors420a,420bare slidably movable relative to one another, thereby adjusting the angle of the first and secondelongate members412a,412brelative to one another. The radius of curvature can vary depending on the curvature of eachconnector420a,420b. Once properly positioned, thefastening element432 can be fully threaded into thebore422bto lock theelongate members412a,412bin a fixed position and at a fixed angle. A person skilled in the art will appreciate that the locking mechanism can be a rivet, pin, bolt or other fastening device known in the art.

In a further embodiment, the complimentary matable surfaces470,472 can include gear teeth formed thereon and adapted to prevent slipping or rotation when thelocking mechanism430 is in a locked position. While a variety of anti-slip features can be formed on the complimentary matable surfaces470,472,FIGS. 4A and 4B illustrate gear teeth (only gearteeth480 on the second connectingfeature420bare shown) formed thereon.

FIG. 5A illustrates another exemplary embodiment of aspinal fixation device500 according to the present invention. In general, the connectingfeature520a,520bon eachelongate member512a,512bis in the form of a protrusion that allows polyaxial movement of theelongate members512a,512brelative to thelocking mechanism530. While the shape of theprotrusion520a,520bcan vary, in the illustrated embodiment the eachprotrusion520a,520bhas a generally bulbous shape. Thelocking mechanism530 includes ahousing510 that is adapted to receive theprotrusion520a,520bof eachelongate member512a,512bsuch that the first and secondelongate members512a,512bare substantially opposed to one another. Additionally, thelocking mechanism530 is adapted to lock the first and secondelongate members512a,512bin a fixed position relative to one another, as shown inFIGS. 5B and 5C.

Thehousing510 of thelocking mechanism530 can have a variety of shapes and sizes, but in the illustrate embodiment, thehousing510 has a substantially rectangular shape and it includes acentral opening585 formed therein and extending between opposed top andbottom surfaces581,582 thereof. Additionally, thehousing510 has at least twoopposed side openings583a,583b, shown inFIG. 5A, extending from opposed first and second side surfaces587,588 thereof. Eachelongate member512a,512bis positioned through the first and secondopposed side openings583a,583bsuch that thebulbous protrusion520a,520bformed thereon is seated within thecentral opening585 of thehousing510. Preferably, each of the first and secondopposed side openings583a,583bin thehousing510 are sized to have a diameter d₁that is smaller than a diameter d₂of thebulbous protrusion520a,520bon eachelongate member512a,512bto prevent thebulbous protrusions520a,520bfrom passing therethrough. The diameter d₁of theopposed side openings583a,583bshould, however, be larger than the diameter d_rof eachelongate member512a,512bto allow theelongate members512a,512bto extend therethrough and to rotate freely. In an exemplary embodiment, theside openings583a,583ballow the first and secondelongate members512a,512bto rotate about 60° in all directions relative to thehousing510, and more preferably to rotate in the range of about 30° to 60°. As a result, the first and secondelongate members512a,512bcan form an angle in the range of about 0 to 120° relative to one another.

As previously stated, thelocking mechanism530 is also adapted to lock theelongate members512a,512bin a fixed position relative to one another. While various techniques can be used to lock theelongate members512a,512bin a fixed position, in the illustrated embodiment thelocking mechanism530 includes afastening element590, which can be a screw, rivet, bolt or other fastening device known in the art, that is adapted to mate to areceiver member592. In the illustrated embodiment, thefastening member590 is a threaded member having a threadedshank590athat is adapted to extend through thecentral opening585 to mate with the receivingmember592, and ahead590bthat is adapted to rest against or sit within a portion of thecentral opening585 formed in thetop surface581 of the housing.

Thereceiver member592 is preferably positioned within a portion of thecentral opening585 that is adjacent to thebottom surface582 of thehousing510, and it has a shape that is effective to lock thebulbous protrusion520a,520bon eachelongate member512a,512bin a fixed position within thecentral opening585 when thefastening element590 is mated thereto. In particular, the receivingmember592 can have a substantially rectangular shape, as shown inFIG. 5C, and it can include opposed concave side surfaces592a,592bformed thereon. In use, thefastening element590 can be threaded into a corresponding threaded bore592cextending through the receivingelement592 to engage the receivingelement592 and pull it into thecentral bore585 formed in thehousing510. As the receivingelement592 moves into thecentral bore585, the opposed side surfaces592a,592babut against thebulbous protrusion520a,520bon eachelongate member512a,512bto lock theprotrusions520a,520bin a fixed position relative to thehousing510.

A person skilled in the art will appreciate that the configuration of theprotrusion520a,520bon eachelongate member512a,512band the receivingelement592 can vary. For example, each connecting features520a,520bcan have a substantially concave recess formed therein, and the receivingelement592 can include convex side surfaces formed thereon for engaging the connectingfeatures520a,520b.

It is possible that some applications will require angular adjustability of only one of the elongate members. Accordingly, in each of the various embodiments of the present invention, one of the elongate members can be angularly adjustable and the other elongate member can maintained in a fixed position.

One skilled in the art will appreciate further features and advantages of the invention based on the above-described embodiments. Accordingly, the invention is not to be limited by what has been particularly shown and described, except as indicated by the appended claims. All publications and references cited herein are expressly incorporated herein by reference in their entirety.

Claims (23)

What is claimed is:

1. A spinal fixation method, comprising:

coupling a first anchor to a first bone;

coupling a second anchor to a second bone;

coupling a first elongate member to the first anchor, the first elongate member having a first connecting feature that is coupled to a second connecting feature formed integrally with a second elongate member such that the second elongate member is movably coupled to the first elongate member;

adjusting an angular position of the second elongate member relative to the first elongate member;

coupling the second elongate member to the second anchor; and

applying a locking mechanism to the first and second connecting features to lock the first and second elongate members in a fixed position relative to one another;

wherein one of the first bone and the second bone is an occipital bone and the other of the first bone and the second bone is a vertebra.

2. The method ofclaim 1, wherein adjusting an angular position of the second elongate member relative to the first elongate member comprises rotating a female portion of the first connecting feature formed on a terminal end of the first elongate member relative to a male portion of the second connecting feature formed on a terminal end of the second elongate member.

3. The method ofclaim 2, wherein the male portion is rotated within a recess defined between opposed arms of the female portion.

4. The method ofclaim 3, wherein at least one of the first and second elongate members rotates about a central mating element disposed within a bore that extends through the male portion and through the opposed arms of the female portion.

5. The method ofclaim 4, wherein the male portion is rotated about the central mating element while the central mating element is fixedly coupled to the female portion.

6. The method ofclaim 1, wherein the locking mechanism engages a central mating element disposed within a bore that extends through a female portion of the first connecting feature formed on a terminal end of the first elongate member and a male portion of the second connecting feature formed on a terminal end of the second elongate member to prevent movement of the male portion relative to the female portion.

7. The method ofclaim 6, wherein the locking mechanism comprises a slot extending through the male portion such that the male portion is in the form of a clamp, and wherein locking the first and second elongate members comprises engaging the male portion with a fastening element to clamp the central mating element within the bore.

8. The method ofclaim 7, wherein engaging the male portion with the fastening element comprises advancing the fastening element into a receiving bore formed in the male portion.

9. The method ofclaim 7, wherein the first and second elongate members are angularly adjustable relative to one another only in a single plane and wherein engaging the male portion with the fastening element comprises advancing the fastening element into the male portion along an axis that is substantially parallel to the single plane.

10. The method ofclaim 1, wherein the first and second elongate members are angularly adjustable relative to one another only in a single plane.

11. The method ofclaim 1, wherein at least one of the first and second elongate members comprises a spinal fixation rod.

12. The method ofclaim 1, wherein at least one of the first and second elongate members comprises a spinal fixation plate.

13. The method ofclaim 1, wherein the first elongate member is a spinal fixation rod and second elongate member is a spinal fixation plate.

14. A spinal fixation method, comprising;

coupling a first elongate member to a first bone, the first elongate member having a first connecting feature integrally formed therewith;

adjusting an angular position of a second elongate member having a second connecting feature integrally formed therewith relative to the first elongate member, the first and second connecting features being movably coupled to each other;

coupling the second elongate member to a second bone; and

applying a fastening element to the second connecting feature and a pin extending from the second connecting feature into the first connecting feature to lock the first and second elongate members in a fixed position relative to each other;

wherein one of the first bone and the second bone is an occipital bone and the first bone and the second bone is a vertebra.

15. The method ofclaim 14, wherein the first and second elongate members are angularly adjustable relative to one another only in a single plane.

16. The method ofclaim 14, wherein coupling the fastening element comprises advancing the fastening element into a receiving bore formed in the first connecting feature.

17. The method ofclaim 16, wherein the first and second elongate members are angularly adjustable relative to one another only in a single plane and wherein the receiving bore extends along an axis that is substantially parallel to the single plane.

18. The method ofclaim 14, wherein the first and second elongate members each comprise a spinal fixation rod.

19. A spinal fixation method, comprising:

adjusting an angular position of a first elongate member having a first connecting feature integrally formed on a terminal end thereof relative to a second elongate member having a second connecting feature integrally formed on a terminal end thereof, the first and second elongate members being movably coupled to each other by the, first and second connecting features;

advancing a fastening element into the first connecting feature such that the fastening element engages a pin member to lock the first and second elongate members in a fixed position relative to each other, the pin member extending from the second connecting feature into a bore formed in the first connecting feature; and

implanting the first and second elongate members in a patient.

20. The method ofclaim 19, wherein implanting the first and second elongate members comprises coupling the first elongate member to a first vertebra and coupling the second elongate member to a second vertebra.

21. The method ofclaim 19, wherein implanting the first and second elongate members comprises coupling the first elongate member to an occipital bone and coupling the second elongate member to a first vertebra.

22. The method ofclaim 19, wherein implanting the first and second elongate members comprises coupling the first elongate member to a first vertebra and coupling the second elongate member to an occipital bone.

23. The method ofclaim 19, wherein adjusting the angular position comprises rotating the first elongate member relative to the second elongate member about a longitudinal axis of the pin member.

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